Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects

The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.

Study Overview

• Status: Completed
• Conditions: Healthy; Alzheimer's Disease
• Intervention / Treatment: Drug: BMS-708163; Drug: BMS-708163; Drug: BMS-708163; Drug: BMS-708163; Drug: BMS-708163

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Mds Pharma Services (Us) Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Young healthy male subjects

Exclusion Criteria:

• Women

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment B	Drug: BMS-708163; Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
Experimental: Treatment A (Reference)	Drug: BMS-708163; Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment C	Drug: BMS-708163; Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment D	Drug: BMS-708163; Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
Active Comparator: Treatment E	Drug: BMS-708163; Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Drug: BMS-708163; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation	Day 1, up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Adverse Events	Day 1, up to 3 weeks
Safety: Vital Signs	Screening, Day 1 and Day 4 of each period
Safety: ECGs	Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests	Screening, Day -1 of each period, Day 1, up to 3 weeks

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): January 7, 2011
• Last Update Submitted That Met QC Criteria: January 6, 2011
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CN156-004